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Thread: Women forced to have hysterectomies to remove Essure device

  1. #51
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    Quote Originally Posted by Shelly View Post
    If patients remain unaware because the doctors they trust continue to deny the cause and these doctors do not report adverse events to the FDA then Bayer's numbers will continue to look good.
    Except its crap, doctors are REQUIRED to report everything. The fear of lawsuit is ridiculous, this Falk guy is a fuckup, and trying to make excuses.

  2. #52
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    Quote Originally Posted by Kontrary View Post
    You can definitely be sued by a pharm company, they can claim you have no basis to say it was due to the product and you filed an adverse event INACCURATELY. Some struggling doctor who has loans and an office to support is no match for a pharm company...plus if you EVER want to get those 100 grand gigs (the ones where you show up and talk as an "expert" about how great a new product is) you better NEVER cross the pharm industry.

    I dont buy you really have such a naive polly-anna view.

    Funny how you think he should have license revoked for even expressing his fear of being sued.

    Of course what you still seem to be not understanding is that all your claims that all was working as it should be is WRONG.....the trials arent nearly as good as you claimed, the doctors cant be trusted to report adverse events...the FDA does not give proper scrutinization.....and I bet you think Bayer is just completely innocent in all this, the biggest benefactors of getting this to market and not having to do more years of clinical trials.
    Please show me an example of this, as I"m pretty sure it is bullshit. The law is all events are supposed to be reported, doctors can't say it wasn't becaue of the product or not, it has to be reported. Somebody can have a hangover and report that to the doctor, it must be reported.

  3. #53
    Veteran Member Kontrary's Avatar
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    Quote Originally Posted by Dr Sampson Simpson View Post
    As usual, this discussion turns to conspiracies based on ignorance of the process.

    OK, people who claim its bad, explain the alternative? Do you realize how much a clinical trial costs? The doctors don't work for the companies, they don't use their big pockets to bribe the FDA, because if the drug is not safe, they pay big time when sued. Doctors don't get paid for their results. Also, most studies are double blinded, how can a doctor, who has no idea which patient got placebo, which got the real drug, influence a clinical trial?

    and as I mentioned, the FDA has big role in aiding in the design of the studies. They direct what type of data they require for approval. What would be the alternative? You don't think if there was independent organizations that did the studies, that there would not be the chance for corruptiona nd mistakes? For a company that has no stake in the game could make a huge mistake in the design of the trial that can kill the drug.

    I really think people need to research this thing more, not finding FDA bashing, biased, one sided internet articles, but from sources that actually hhave done the trial.

    And the rate of approval would be far greater by the FDA, and you would not have companies complaining about the high standards set by the FDA, if corruption was involved. There would be far more drugs, because an unapproved drug costs a company millions and millions.

    And a drug which is unsafe put on the marking knowingly by the company would cost them billions.
    There is no conspiracy theory here, you just pretend to ignore how real the corruption is and the obvious flaws that are built into the system.

    The ones who are making sure this gets looked at are the victims...not the FDA, not the medical industry, not Bayer, not the pharm industry....that alone says plenty.

  4. #54
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    Quote Originally Posted by Kontrary View Post
    You can definitely be sued by a pharm company, they can claim you have no basis to say it was due to the product and you filed an adverse event INACCURATELY. Some struggling doctor who has loans and an office to support is no match for a pharm company...plus if you EVER want to get those 100 grand gigs (the ones where you show up and talk as an "expert" about how great a new product is) you better NEVER cross the pharm industry.

    I dont buy you really have such a naive polly-anna view.

    Funny how you think he should have license revoked for even expressing his fear of being sued.

    Of course what you still seem to be not understanding is that all your claims that all was working as it should be is WRONG.....the trials arent nearly as good as you claimed, the doctors cant be trusted to report adverse events...the FDA does not give proper scrutinization.....and I bet you think Bayer is just completely innocent in all this, the biggest benefactors of getting this to market and not having to do more years of clinical trials.

    naive? YOu guys believe in conspiracies, based on biased website articles, and with no knowledge of the process, the science, the medicine. I'm very familiar with the entire process, the science, the research, the study designs, the necessary data, FDA's rules.

    Is there fraud? yes, there is with everything. Wha'ts naive is to think there is with every drug, every company. What's also is just outright stupid, is the thought that a company would potentially risk serious jail times, fines, and lawsuits that would cost far more than they can make on a drug, by purposely fudging the data. If something is unsafe, they want to know about it, and legally have to report it.

    And its been conveniently been ignored the fact there has been more than 5 years of follow up post-market monitoring by the FDA, not based on the clinical trials.
    Last edited by Dr Sampson Simpson; 15th November 2013 at 09:21 AM.

  5. #55
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    Quote Originally Posted by Kontrary View Post
    There is no conspiracy theory here, you just pretend to ignore how real the corruption is and the obvious flaws that are built into the system.

    The ones who are making sure this gets looked at are the victims...not the FDA, not the medical industry, not Bayer, not the pharm industry....that alone says plenty.
    Ah yes, can't back up things with fact, just claim I'm ignoring them. There are flaws with everything, and you would be amazed at how high of standards FDA sets for these trials. That's if you had a clue about any of it, and that's fine, there are lots of things I'm not very well educated on. But if you do, back it up. Show me where doctors have been sued by reporting negative data? what about the 5 years post market studies? Or the fact that nearly everything in life can have a negative side effect in a portion of the population.


    You guys act like since things are not perfect, everything must be fraud. That's naive

  6. #56
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    Quote Originally Posted by Dr Sampson Simpson View Post
    naive? YOu guys believe in conspiracies, based on biased website articles, and with no knowledge of the process, the science, the medicine. I'm very familiar with the entire process, the science, the research, the study designs, the necessary data, FDA's rules.
    Ok so the woman DIDNT complain of pain and they put her down as "excellent" regarding her comfort level? Thats some conspiracy? Its not a biased study? Any study done by the company who stands to profit from a specific outcome IS biased, its a BIASED party who is funding and controlling it.

    Its not a conspiracy that things have not worked as "they should". If they had, this would have been caught and the people who participated in the clinical trials would have been ACCURATELY reported in regards to their problems and pain.

    Its a conspiracy that a doctor who SUPPORTS the product also says he fears reporting adverse events to the FDA because he fears being sued? You think he is the only doctor who feels that way?

    I know its an easy tack to take labeling a person a "conspiracy theorist" so you can dismiss anything a person says, but there are facts here, not opinions. Reporting lower back pain and having a researcher check "excellent" is a fact, not an opinion. That means its a BAD study that got this approved. Thats a fact. The FDA didnt scrutinize this study well enough, if they had, they would have seen this was a problematic study....(3 positive responses, one neutral and only one negative..that a problem right there)....thats a fact too.

  7. #57
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    Quote Originally Posted by Kontrary View Post
    Ok so the woman DIDNT complain of pain and they put her down as "excellent" regarding her comfort level? Thats some conspiracy? Its not a biased study? Any study done by the company who stands to profit from a specific outcome IS biased, its a BIASED party who is funding and controlling it.

    Its not a conspiracy that things have not worked as "they should". If they had, this would have been caught and the people who participated in the clinical trials would have been ACCURATELY reported in regards to their problems and pain.

    Its a conspiracy that a doctor who SUPPORTS the product also says he fears reporting adverse events to the FDA because he fears being sued? You think he is the only doctor who feels that way?

    I know its an easy tack to take labeling a person a "conspiracy theorist" so you can dismiss anything a person says, but there are facts here, not opinions. Reporting lower back pain and having a researcher check "excellent" is a fact, not an opinion. That means its a BAD study that got this approved. Thats a fact. The FDA didnt scrutinize this study well enough, if they had, they would have seen this was a problematic study....(3 positive responses, one neutral and only one negative..that a problem right there)....thats a fact too.
    Now you are just moving the goalposts, deflecting and making up what I'm saying. A telling sign that you are not very well informed on this topic and don't really have a strong case to back it up.

    I addressed the doctor thing- what he did was wrong, but trying to blame it on the company and fear of being sued is complete BS on the doctors part.

    The biased study, sorry, its not a biased study, all the data is presented to the FDA, they can see it, they make determination based on the data, not what the company says. I already mentioned the FDA has a role in the design of the study, and these studies have to be approved by the FDA prior to them taking place. Any hiccup in the study, changes, must be approved by the FDA, with their input. A doctor not doing their jobs, that's on the doctor if its true he checked excellent when patients said no such thing. Even in the article, the claim that he held the data back because he thought it wasn't caused by the device, that's not ethical, probably is illegal. The studies must report everything a patient reports, so the doctor is the one that seemed to fuck up.

    Also, already addressed the company that could make millions on the study, what good does that do when you lose billions when you are sued for putting out a bad drug/device based on fraudulent data?

    Again, you have nothign to back up the claim that a doctor performing a clinical trial can get sued for reporting bad data. Umm, why do so many drugs fail to get approval by the FDA if this was the case? Again, the claim is bullshit, if you don't want to admit it, at least make an attempt to back it up.

    Also, you ignored, once again ,the 5 years of post market follow up,.

    You are not presenting facts, that's the point. And spinning a biased article not presenting data but individuals comments, some with not knowledge of the process, and only presenting one side, without informing the reader of how the process work, those are not facts. Not one comment in article about from the people that have benefited form the prodcut and probably love it.

    When you refuse to acknowledge all these points and continue to push the false claims you are, that sound pretty conspiracy to me.

    All I'm doing is informing people of the process and representing the other side, which the article does not. But most lay people this uninformed, the big bad pharma companies must be nefarious, evil people out to get us and fudging data.

    The facts don't really add up, and pointing to cases of fraud to smear and entire industry and process, that's pretty disingenuous.
    Last edited by Dr Sampson Simpson; 15th November 2013 at 10:35 AM.

  8. #58
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    Quote Originally Posted by ptif219 View Post
    So no deaths means it is okay? The FDA did one study by an outside group and that is it? Women having to get sick and having hysterectomy is nothing?

    Kep trying but this is no small deal and it has the attention of local news all over the country as I have shown. This is not the end of this and the FDA should do it's job and find this unsafe. Part of the problem is the device is made from nickel which m,any women are having a reaction to
    Let me guess, the only birth control you approve of is abstinence.

  9. #59
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    Quote Originally Posted by OldGaffer View Post
    This is why they have lawyers. I do not believe Obama is installing those devices or even knows about them.
    Of course, Obama doesn't know.

    Girl stuff.

    How much do you know about it?

  10. #60
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    Quote Originally Posted by Blueneck View Post
    Let me guess, the only birth control you approve of is abstinence.
    Let me guess, the only birth control you approve of is abortion.*










    *See how silly and pointless it is?
    Thanks from ptif219

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